CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC 3000 (REF 300025MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00690103162264), received between Feb 12, 2021 and Feb 12, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3000TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24328962 ↗
• InjuryAug 27, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 11 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22905130 ↗
• InjuryNov 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MODEL 3000 25MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 7 MONTHS DUE TO UNKNOWN REASONS. A 9755RSL 23MM TRANSCATHETER VALVE WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 20664591 ↗
• InjurySep 23, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 25MM 3000 IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION, CHEST DISCOMFORT, AND SYNCOPE. THE PROCEDURE WAS PERFORMED WITH A 23MM SIZE 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 20285709 ↗
• InjuryMay 24, 2024Calcified; Calcified

  IT WAS REPORTED THAT A 25MM 3000 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, 5 MONTHS DUE TO CALCIFICATION. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19397860 ↗
• InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE IS BEING WORKED UP FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 10 MONTHS DUE TO UNKNOWN REASON. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19280154 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 4 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 19149406 ↗
• InjuryDec 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18387785 ↗
• InjuryAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX YEARS, SIX MONTHS DUE TO UNKNOWN REASON. THE REPLACEMENT VALVE IS 25MM 11500A AORTIC VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17657902 ↗
• InjuryAug 28, 2023Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND LATER THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 7 MONTHS DUE TO CALCIFIED LEAFLETS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A AORTIC VALVE. THE PATIENT WAS STABLE AND TRANSFERRED TO ICU POST PROCEDURE. THE PATIENT WAS DISCHARGED ON POD #6. THE PATHOLOGY REPORT CONFIRMED DIFFUSELY CALCIFIED LEAFLETS.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 17637550 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 25MM 3000 VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVE. PATIENT WAS IN RECOVERY POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 16852889 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO ENTEROCOCCUS FAECALIS ENDOCARDITIS WITH AORTIC ANNULAR INFECTION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT POST-PROCEDURE IN RECOVERY. THE PATIENT EXPIRED POD#28 PER ADDITIONAL INFORMATION: THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS OF THE AORTIC VALVE APPROXIMATELY 10 WEEKS PRIOR TO THE 25MM 3000 AORTIC VALVE EXPLANT.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 16655606 ↗
• InjuryFeb 23, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  EDWARDS RECEIVED INFORMATION A PATIENT WITH A 25MM 3000 AORTIC VALVE IMPLANTED SEVEN (7) YEARS, THREE (3) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS AND MILD CENTRAL AORTIC REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND HYPERTROPHIC CARDIOMYOPATHY A 26MM 9750TFX TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE 25MM VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16427567 ↗
• InjuryOct 31, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, THREE (3) MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND SENT TO RECOVERY.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 15700221 ↗
• InjuryJun 17, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 15 YEARS, NINE (9) MONTHS DUE TO SEVERE SYMPTOMATIC STENOSIS. THE PATIENT PRESENTED WITH ACUTE ON CHRONIC DIASTOLIC CHF. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THERE WAS NO INVESTIGATIONAL EVIDENCE OF A PREMATURE FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 12021911 ↗
• InjuryFeb 12, 2021Gradient Increase; Appropriate Device Problem Term/Code Not Available; Gradient Increase; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FIVE (4) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE TAVR WAS PERFORMED WITH A 26MM 9600TFX. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. ON POD #1, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Aortic Valve Stenosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11324357 ↗